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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dental stereotaxic instrument
510(k) Number K161399
Device Name Neocis Guidance System
Applicant
Neocis Inc.
2800 Biscayne Blvd Suite 600
miami,  FL  33137
Applicant Contact alon mozes
Correspondent
Neocis Inc.
2800 Biscayne Blvd Suite 600
miami,  FL  33137
Correspondent Contact alon mozes
Regulation Number872.4120
Classification Product Code
PLV  
Date Received05/20/2016
Decision Date 12/22/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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